Combined Hepatitis A and B vaccine

The latest Journal of the American Medical Association reports on the FDA approval of an alternate dosing schedule for a combined Hep A and B vaccine.

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Researchers from GlaxoSmithKline Biologicals in Pennsylvania, USA received Food and Drug Administration Approval of an Alternate Dosing Schedule for a Combined Hepatitis A and B Vaccine (Twinrix®).

GlaxoSmithKline Vaccine Division received approval in April 2007 from the Food and Drug Administration for an alternate schedule for Twinrix®.

The Journal of the American Medical Association

Twinrix® is a combined Hepatitis A and Hepatitis B vaccine.

Twinrix® was first licensed by Food and Drug Administration in 2001 on a 3-dose schedule (0, 1, and 6 months) for vaccination of persons aged 18 years.

The researchers used the newly licensed, alternate 4-dose schedule.

Twinrix® doses can be administered at 0, 7, and 21 to 30 days, followed by a dose at 12 months.

The researchers found in immunogenicity studies among adults aged 18 years, that the first 3 doses of the alternate schedule provided equivalent protection to the first 2 doses in the standard 3-dose Twinrix® series.

The researchers concluded, "The first 3 doses of the alternate schedule also have proven effective in providing protection."

"This is equivalent to a single dose of monovalent Hepatitis A vaccine and to 2 doses of monovalent Hepatitis B vaccine.